Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
NCT07116967
Plaque Psoriasis
Birmingham, Alabama, United States
View Trial DetailsNCT Number: NCT07683065
This study aims to examine the retention rate of secukinumab in adult patients with plaque psoriasis (with or without psoriatic arthritis [PsA]) and metabolic dysfunction-associated steatotic liver disease (MASLD) in routine clinical practice in Spain, as well as hepatic biomarker trajectories. The study will use electronic medical record (EMR) data from multiple Spanish hospitals.
Interested in participating?
Request Info18 year–100 year
All sexes
Observational
Novartis Investigative Site, Badalona, Barcelona, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply.
Time frame: Up to 5 years
Definitive discontinuation is defined as the date of first documentation of secukinumab discontinuation or biologic switch, whichever is recorded first.
Time frame: Up to 5 years
Discontinuation due to lack of response is defined as the first documentation of secukinumab discontinuation or biologic switch due to lack of response or similar assessment, whichever is recorded first
Time frame: 12 and 24 months
PASI is a combined assessment of lesion severity and affected area into a single score. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a maximum of 72.0. The body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area multiplied by the area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A PASI 100 response corresponds to complete clearing of psoriasis (PASI = 0).
Time frame: 12 and 24 months
PASI is a combined assessment of lesion severity and affected area into a single score. The body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area multiplied by the area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a maximum of 72.0.
Time frame: Baseline up to 5 years
FIB-4 is a non-invasive tool used to assess liver fibrosis. The FIB-4 score is calculated using age, aspartate aminotransferase (AST) level, alanine aminotransferase (ALT) level, and platelet count.
FIB-4 fibrosis risk categories:
Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
FIB-4 and aspartate aminotransferase to platelet ratio index (APRI) are non-invasive tools used to assess liver fibrosis. The scores are calculated using age, AST level, ALT level, and platelet count
FIB-4 fibrosis risk categories (patients aged ≥35 years):
APRI risk categories (patients aged <35 years):
Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
FIB-4 is a non-invasive tool used to assess liver fibrosis. The FIB-4 score is calculated using age, AST level, ALT level, and platelet count.
FIB-4 fibrosis risk categories:
Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
APRI is a non-invasive tool used to assess liver fibrosis. The APRI score is calculated using AST level and platelet count
APRI risk categories:
Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
Time frame: Baseline to 12 and 24 months
Associations between changes in the level of liver fibrosis (FIB-4) and changes in the severity of psoriasis (PASI) will be explored using Spearman correlations.
Time frame: Baseline to 12 and 24 months
Associations between changes in the level of liver fibrosis (APRI) and changes in the severity of psoriasis (PASI) will be explored using Spearman correlations.
Contact information is provided by the study sponsor or research team.
Novartis Pharmaceuticals
Industry
SEC-HOPE: A Multicenter Retrospective Cohort Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD
Acronym: SEC-HOPE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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